- ‘Pharma bro’ fraudster Martin Shkreli ordered to pay $388,000 in restitution to swindled investor (cnbc.com)
A federal judge...ordered "pharma bro" scammer Martin Shkreli to immediately pay a defrauded hedge fund investor about $388,000 in restitution, roughly half of what the investor asked for… The order comes a month after Judge Kiyo Matsumoto sentenced Shkreli to seven years in prison for defrauding that investor, Richard Kocher, and a number other people, as well as for conspiring to manipulate stock shares...In addition to his prison sentence, Matsumoto also imposed a fine of $75,000 on the 35-year-old Shkreli and ordered him to forfeit almost $7.4 million in assets to the federal government...
- Many Well-Known Hospitals Fail To Score High In Medicare Rankings (npr.org)
The federal government released its first overall hospital quality rating...slapping average or below average scores on many of the nation's best-known hospitals while awarding top scores to many unheralded ones....The Centers for Medicare & Medicaid Services rated 3,617 hospitals on a one- to five-star scale, angering the hospital industry, which has been pressing the Obama administration and Congress to block the ratings...Hospitals argue that the government's ratings will make teaching hospitals and other institutions that treat many tough cases look bad. They argue that their patients are often poorer and sicker when admitted, and so are more likely to suffer further complications or die, than at institutions where the patients aren't as sick...Rick Pollack, president of the American Hospital Association, called the new ratings confusing for patients and families..."We are especially troubled that the current ratings scheme unfairly penalizes teaching hospitals and those serving higher numbers of the poor."..."Hospitals cannot be rated like movies," Dr. Darrell Kirch, president of the Association of American Medical Colleges..."We are extremely concerned about the potential consequences for patients that could result from portraying an overly simplistic picture of hospital quality with a star-rating system that combines many complex factors and ignores the socio-demographic factors that have a real impact on health."
- New FDA policy gives its staff wide latitude on social media. Could pharma freedom follow? (fiercepharmamarketing.com)
Tweet at will, FDA employees. One of the most liberal social media policies in the federal government now belongs to the FDA. Just last month, the FDA finally set out its own departmental policy that encourages its scientists and other employees to use "social media technologies to enhance communication, collaboration, and information exchange in support of FDA's mission to protect and promote public health."...While many would argue that the guidelines for pharma and other medical regulated products on social media outlined so far by the FDA have had a chilling effect on the industry's social media use, especially Twitter, its own FDA employee guidelines should have quite the opposite effect...
- Pfizer-Allergan Merger Raises Concerns That Fraud Is Part Of ‘Corporate DNA’ (forbes.com)
The massive Pfizer-Allergan merger is getting a lot of attention. It is one of the largest takeovers ever in the healthcare industry, worth an estimated $160 billion…But consider another number: The amount Pfizer, Allergan and their predecessor companies have paid to settle government healthcare fraud allegations in the US – a total of nearly $4.5 billion. That total doesn’t include close to $1 billion paid to settle related consumer actions…Add to that the six criminal pleas and four corporate integrity agreements that the companies and their predecessor subsidiaries have agreed to, and one might question whether cheating and corruption are part of their “corporate DNA.”… The duo’s “hall of shame” is staggering and impossible to overlook. Here are some of the settlements the two corporations and/or their predecessor companies have paid the US and states:
- Pfizer/Parke Davis/Warner Lambert — $430 million settlement and a criminal plea. (2004)
- Pfizer/Pharmacia & Upjohn Co. — $2.3 billion and a criminal plea. (2009)
- Allergan — $600 million and a criminal plea. (2010)
- (Allergan/Actavis) Forest Labs — $313 million and a criminal plea. (2010)
- Pfizer — $14.5 million. (2011)
- (Allergan/Actavis) Watson Pharmaceuticals — $1.7 million. (2012)
- Pfizer/Wyeth Pharmaceuticals — $491 million and a criminal plea. (2013)
- Allergan/Actavis/Watson Pharmaceuticals — $12.4 million. (2013)
- Pfizer/Wyeth — $35 million. (2014)
- Allergan/Warner Chilcott — $125 million and a criminal plea. (2015)
- US OKs medical isotope system that isn’t based on bomb-grade uranium (cnbc.com)
The federal government...approved a device made by a private company...that will allow the first domestic production of a medical imaging isotope...a move the government said would enhance national security by reducing the need to transport weapons-grade uranium...The Food and Drug Administration granted the approval to NorthStar Medical Radioisotopes, which said it would begin delivering systems to make technetium-99...the most common isotope in medicine and is used in 40,000 procedures a day in the United States...consumers have long had to depend on a complicated and risky supply chain for the materials...The current process involves shipping weapons-grade, or highly enriched, uranium from the United States to research reactors in Australia, South Africa and Europe where it is irradiated to make molybdenum-99, which decays into technetium-99..."This is a win for our national security," said Peter Hanlon, an official with the National Nuclear Security Administration office of material management and minimization...
- Obama Declares ACA Success in JAMA, Calls for Taking Steps to Reduce Drug Costs (ajmc.com)United States Health Care ReformProgress to Date and Next Steps (jama.jamanetwork.com)
President Barack Obama today declared in a special issue of JAMA that the Affordable Care Act has worked, both by driving down the share of Americans without health coverage and by "transforming healthcare payment systems," that are improving quality and reining in spending...The president’s article, "United States Health Care Reform: Progress to Date and Next Steps," highlights what he sees as the achievements of the signature law often called "Obamacare," while calling for more work to cut prescription drug prices and fill gaps where market competition is lacking, perhaps with a "public option."..."Americans can now count on access to health coverage throughout their lives, and the federal government has an array of tools to bring the rise of healthcare costs under control," Obama writes. "However, the work toward a high-quality, affordable healthcare system is not over."
- EHR use a ‘frustrating’ time suck, physicians tell American Medical Association (healthcareitnews.com)Providers press for delay, flexibility in EHR rule (modernhealthcare.com)
...more physician groups are making the case that stringent regulations and suboptimal technology have left physicians spending too much time grappling with their electronic health records...It's not that physicians are against health IT. In fact, most have adopted technology "at a blistering pace,"...But unrealistic and uncoordinated requirements are overburdening physicians' time and affecting the quality of patient care...AMA published a list titled "How EHRs tied up physician time in 2015."...EHR technology continues to underwhelm...Meaningful use is outliving its usefulness...Physicians are talking back -- and being heard...the Association of American Physicians and Surgeons also put out a strongly worded complaint this week, charging that EHRs could "crash" the U.S. healthcare system..."EHRs are supposed to be a cure-all for inefficiency and medical errors,"..."But the costly, clunky systems the government demands are worsening the problems and even driving some software experts back to paper."..."It's a major distraction from face-to-face patient care and interaction, thereby increasing the chance of missing important information, and in the end, increasing the probability of clinical and treatment errors,"..."The federal government should have no role in telling how physicians how to keep their records,"...
- Hospitals file lawsuit to block 340B drug payment cut (biopharmadive.com)
The American Hospitals Association and other organizations have made good on their promise to sue the federal government in an effort to halt a major cut planned for the 340B Drug Pricing Program...The hospitals are arguing the reimbursement change exceeds the authority of the HHS secretary and is "arbitrary and capricious." They ask the court to force HHS to delay implementation or strike the cut entirely...HHS released a final rule earlier this month that changes the amount 340B hospitals will be paid for most drugs to 22.5% less than the average sales price starting at the beginning of next year. Currently those hospitals are paid the average price plus 6%...The cut of about 30% would hurt nonprofit hospitals' margins, according to a recent report from Moody's. The CMS has argued the change would reduce out-of-pocket costs and improve patient-provider relationships. The agency has calculated the 340B cut would save about $900 million next year...AHA has been strongly critical of the cut, saying it threatens patient care, particularly for vulnerable populations that are most likely to use safety net hospitals benefiting from the drug payment program...A recent report found 340B hospitals had a larger decrease in charity care spending than other hospitals, but AHA said the study was misleading and incomplete.
- Drug Price Control: How Some Government Programs Do It (commonwealthfund.org)
The federal government already has several tools for reducing the prices of drugs it buys...The VA and DOD pay drug prices that are roughly half as much as those paid by retail pharmacies...Drug pricing is having its moment. Proposed treatments for the drug pricing epidemic are varied, but some call for government to do more...While others resist the idea of government involvement, the federal government, in fact, already employs a number of effective tools for reducing the prices of drug purchased by certain public programs. These fall into two broad categories:
- Price controls, usually in the form of required discounts off of the average price paid by other purchasers.
- Negotiated pricing, in which the government wields its market power to bargain for favorable rates from pharmaceutical suppliers.
These strategies do not exhaust the available approaches, nor are they necessarily the most desirable...The Programs:
- Medicaid
- Veterans Health Administration and the Department of Defense (DOD)
- 340B Program
The bottom line is that the government can and does get better deals on drugs than private purchasers. The effects of these policies on quality and innovation need to be better understood—but were the government to expand them, it would be more of an evolution than a revolution.
- The untold story of TV’s first prescription drug ad (statnews.com)
On May 19, 1983, Boots aired the first broadcast television commercial in the United States for a prescription drug, the pain reliever Rufen...Within 48 hours of the ad’s airing, the federal government told the company to take it down. And more than 30 years later, the fight over marketing prescription drugs directly to the public is still raging...Now, the American Medical Association, the largest doctors group in the United States, wants to stop direct-to-consumer advertising for prescription drugs in the belief that the ads encourage patients to seek medicines unnecessarily. But the effort to have drug ads banned alongside tobacco ads will face plenty of obstacles, none bigger than the First Amendment. Perhaps the most unusual thing about this decades-long saga is that it’s an issue at all...The United States is one of only two countries in the world to allow these ads. How did this little-noted example of American exceptionalism come to be?...It started with Boots.